Customizable Angioplasty Balloon-Forming Machine: Towards Precision Medicine in Coronary Bifurcation Lesion Interventions.

The ability to customize the size and shape of angioplasty balloons may be useful in many clinical and research applications of coronary and endovascular intervention. Fully customizable balloons are outside the reach of most researchers due to their prohibitive cost. A small-scale balloon-forming machine was developed to produce fully customizable balloons. This study describes the creation of this customizable balloon-forming machine and identifies the key components of manufacturing a patient-specific balloon. Using a standard balloon-shaped mold created with a novel application of 3D stereolithography-printed resin, 104 PET balloon formation tests were conducted. A statistical study was conducted in which molding temperature and inflation air pressure were independent variables ranging from 100 to 130 °C and from 3.7 to 6.8 atm, respectively. The criteria for balloon-forming success were defined; pressure and temperature combined were found to have a significant impact on the success (p = 0.011), with 120 °C and 4.76 atm resulting in the highest chance for success based on a regression model.